required pursuant to any applicable Health Care Laws, nor has the Company received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental authority or any other third party alleging that any product, operation, or activity is in material noncompliance with any applicable Health Care Laws or Government Licenses; nor, to the Company’s knowledge, is any such written notice, claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action threatened. Except as would not be expected, individually or in the aggregate, to result in a Material Adverse Effect, the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments (“Submissions”) as required by any applicable Health Care Laws, and all such Submissions were accurate on the date filed (or were corrected or supplemented by a subsequent submission). The Company is not a party to any corporate integrity agreements, deferred or non-prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Governmental Entity. Neither the Company nor any of its respective employees, officers, directors, or, to the Company’s knowledge, agents has been excluded, suspended or debarred from participation in any U.S. federal health care program or human clinical research.
(xlii) Clinical Studies. The preclinical studies, clinical trials and tests conducted or sponsored by or on behalf of the Company, or in which the Company has participated with respect to their products or product candidates, including without limitation, any such studies, tests and trials that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package, and the Prospectus (collectively “Studies”) were and, if still pending, are being conducted in all material respects in accordance with all applicable Health Care Laws, Government Licenses, and any protocols to which such studies, tests, or trials are or were subject; each description of such Studies, and the results thereof, contained in the Registration Statement, the General Disclosure Package and the Prospectus is accurate in all material respects, and the Company has no knowledge of any other studies or tests, the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; the Company has not received any written notices or other written correspondence from the FDA or any other federal, state, local or foreign governmental or regulatory authority, or any institutional review board having authority over the conduct of such Studies, requiring or threatening the termination, suspension or material modification of any Studies currently being conducted or proposed to be conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such Studies, and, to the Company’s knowledge, there are no reasonable grounds for the same.
(xliii) Safety Notices. The manufacture of the Company’s products by or, to the knowledge of the Company, on behalf of the Company, is being and since January 2021, has been, conducted in compliance in all material respects with all applicable Health Care Laws, including, without limitation, the FDA’s current good manufacturing practice regulations codified at 21 C.F.R. Part 820, and, to the extent applicable, the respective counterparts thereof promulgated by governmental authorities in countries outside the United States. Except as disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, there have been no material recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company’s products (collectively, “Safety Notices”); and (ii) to the Company’s knowledge, there are no facts that would be reasonably likely to result in (x) a material Safety Notice with respect to the Company’s products, (y) a material change in labeling of any the Company’s products due to safety or efficacy concerns, or (z) a termination or suspension of marketing or testing of any the Company’s products.
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